The Ministry of Health responded to the refusal to synthesize Sputnik V and AstraZeneca
Earlier it was reported that the ethics committee of the Ministry of HEALTH did not approve joint studies. The ministry explained that the decision has not yet been made,
Earlier information that appeared in the media about the impossibility of conducting a joint clinical trial of ASTRAZENECA and Sputnik V vaccines is not true. This was reported to RBC in the press service of the Ministry of Health.
“The decision on the possibility of conducting this clinical trial will be made by the Ministry of Health of RUSSIA on the basis of the conclusions of the expert organization and the ethics council in the prescribed manner after the applicant submits the previously requested documentation,” the ministry said.
The Ministry of Health stressed that the previously published opinion of the ethics council was prepared due to the absence in the application for a clinical trial of a number of documents and data necessary to assess the ethical and clinical aspects of the study, as well as to characterize the efficacy and safety of the study drugs.
The media learned about the refusal to test the Sputnik V bundle with AstraZeneca Society
“It is important to note that the missing information was requested on April 26 from the Federal State Budgetary Institution “Scientific Center for Expertise of Medicinal Products” and has not been submitted to the Russian Ministry of Health so far. Upon receipt of the specified data, they will be sent to the Federal State Budgetary Institution "NTsESMP" of the Ministry of Health of Russia and the Ethics Council for an examination," the press service added.
Previously, Pharmvestnik reported that the ethics committee of the Ministry of Health opposed human trials of the combination of AstraZeneca and Sputnik V vaccines. The publication referred to a document on the first and second phases of trials of the combination of AZD1222 and rAd26-S vaccines in adults (these codes refer to the British and Russian vaccines, respectively).
AstraZeneca said they have not received official confirmation from the ethics committee about the decision regarding the study. “This information does not mean that the study has not been approved. The questions asked by the ethics committee are related to the originally submitted documents, ”the company explained.
German scientists say they have found a link between the AstraZeneca vaccine and blood clots
The creators of Sputnik V proposed a joint study of the two vaccines last November. In December, AstraZeneca announced that it was starting trials of drug bundles. The combination of different vaccines can be an important step in the prevention of covid-19 , the company noted.
In the spring of this year, the AstraZeneca vaccine scandal broke out - it was discovered that in rare cases, an injection can lead to blood clots. In Europe, about 500 such cases were recorded, some of them ended in death. Some countries have suspended the use of the vaccine in their vaccination campaigns.
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